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Clinical trials basic results information is required by law to be reported to the FDA ClinicalTrials.gov web site, as of September 2008. All clinical trial basic results data for FDA-approved clinical trials should be reported. This covers both FDA regulated clinical studies, drugs, and medical devices. Due to the volume and/or complexity of clinical trial basic results data, software may be used to convert basic results Excel spreadsheets into ClinicalTrials.gov basic results XML for uploading to the PRS Protocol Registration System web site. With MedPhaseSoftware solutions, software can be integrated with external data sources to generate and author the required XML to support basic results submission requirements for ClinicalTrial.gov.
Typically, basic results information from a clinical study includes several pieces of key information which are to be disclosed, including baseline characteristics, primary outcomes, secondary outcomes, and statistically relevant analyses. This information is prepared from a combination of the clinical trial protocol information (prepared upon creation of the clinical study) and basic summary results, prepared from the basic results data of the clinical trial. All key fields of information may be stored within an Excel file and used to covert to ClinicalTrials.gov XML format for uploading and reporting of basic results.
Basic results for a clinical trial are required within 1 year after the completion date (estimated or actual, whichever is earlier) of a clinical trial. Basic results data may be manually entered or uploaded via XML format to the clinicaltrials.gov PRS system web site for processing. Basic results data will then be reviewed and published by the FDA clinicaltrials.gov system for the corresponding clinical study. Penalties may be imposed for clinical trials in non-compliance of basic results reporting.
Clinical trial basic results data includes six core areas of information, ranging from Participant flow (number of patients included, excluded, and change during the trial), Baseline measurements (overall demographic and baseline data for specific arms of the clinical study, gender, age, and any other user-defined measures), Outcome measures (primary and secondary outcomes, safety issues, and time-frames), Statistical analysis (data recorded of statistical significance for specific outcome measures), Serious Adverse Events SAE (expected and unexpected serious adverse events, frequency, number, etc), and Frequent Adverse Events FAE.
Basic results data may be manually entered directly in the FDA ClinicalTrials.gov PRS online web site or by creating and uploading a basic results XML format data file. Due to the complexity of the data by nature, manual data entry of clinical trial basic results may be time-consuming, depending on the complexity and number of clinical trial basic results to report. Through the use of software tools and clinical trial basic results conversion software, basic results data may be converted into XML format for upload to the clinicaltrials.gov web site. The software would allow selection of key tables and fields from the Excel file for mapping to corresponding ClinicalTrials.gov XML basic results fields, preparing the XML for upload and validation in the FDA Protocol Registration System.
Typically, clinical trial basic results data may be converted from a proprietary format into an Excel (xls) file. Once converted to an Excel spreadsheet, software may be used to convert the Excel format into ClinicalTrials.gov Basic Results XML format. Finally, the basic results XML file may be uploaded to the clinicaltrials.gov PRS Protocol Registration System. It's important to note that the data definition document for the basic results XML format may be updated in the future. Changes to the clinicaltrials.gov basic results XML format should be reflected in the software and external data source mapping which converts Excel to basic results XML.